BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFSUION PUMP

    MDR report key: 1884695 · Received October 25, 2010

    Report

    Report Number
    2531779-2010-01883
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. DURING EVAL, THE 'UP' 'DOWN' AND 'OK' BUTTONS REQUIRED MULTIPLE PRESSES TO RESPOND. THE KEYPAD WAS REMOVED AND ADHESIVE WAS OBSERVED UNDER THE BUTTON CONTACTS.

    Description of Event or Problem · 1

    THE PT'S FATHER REPORTED THAT THE 'UP' 'DOWN' AND 'OK' BUTTONS. NO TRAUMA TO THE PUMP OR EXPOSURE TO MOISTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFSUION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR